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Can a gentle eye scan replace stressful exams for preterm infants?

NCT ID NCT07738874

Diagnosis Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This study tests whether a handheld, ultra-widefield eye scanner (OCT) can accurately identify preterm infants with severe retinopathy of prematurity (ROP), a condition that can harm vision. The scanner takes detailed images of the retina without touching the eye, potentially reducing stress compared to standard exams. Researchers will compare the scanner's accuracy against traditional methods and also measure infant stress during imaging. The goal is to develop a more objective, low-stress screening tool to improve early detection and treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ultra-widefield optical coherence tomography (OCT) imaging and wide-field fundus imaging
What this could lead to
If successful, this could lead to a gentler, more accurate way to screen preterm infants for severe ROP, potentially preventing vision loss.
What could go wrong
The imaging may not be as accurate as standard exams, and the stress of imaging could affect infants. Results are early and need validation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 175 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 days to 9 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Health care provider, knowledgeable of protocol, agrees that study personnel could contact the Parent/Legal guardian * Parent/Legal Guardian is able and willing to consent to study participation for the infant * Infant meets the American Association of Pediatrics eligibility of ROP screening, and is age \< 35 weeks postmenstrual age at first visit * Infants transferred to nursery for ROP treatment (some participants) Exclusion Criteria: * Participant or Parent/Legal Guardian unwilling or unable to provide consent * Adult participant or infant/child has a health or eye condition that preclude eye examination or retinal imaging (e.g. corneal opacity such as with Peter's anomaly or cataract) * Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly)

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Conditions

The condition(s) this trial relates to.

eye disorder Infant, Newborn, Diseases Infant, Premature, Diseases Obstetric Labor Complications Obstetric Labor, Premature pregnancy disorder Premature Birth retinal disorder retinopathy of prematurity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Retinopathy of prematurity (ROP)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke University Eye Center

    RECRUITING

    Durham, North Carolina, 27705, United States

  • University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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